ROBI 38710ONRecalls & reported problems
Karl Storz GmbH & Co. KG · RoBi® Forceps Insert · Class 2
All models of ROBI (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04048551328835), received between Dec 16, 2025 and Dec 16, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Sparking” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Sparking3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2025Sparking; Sparking
IT WAS REPORTED: "FORCEP SPARKING AND SMOKING. INSULATION HAS SEPARATED FROM THE COLLAR WHERE IT GOES INTO THE HANDLE ON ALL ITEMS." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23817626 ↗MalfunctionDec 16, 2025Sparking; Sparking
IT WAS REPORTED: "FORCEP SPARKING AND SMOKING. INSULATION HAS SEPARATED FROM THE COLLAR WHERE IT GOES INTO THE HANDLE ON ALL ITEMS." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23817625 ↗MalfunctionDec 16, 2025Sparking; Sparking
IT WAS REPORTED: "FORCEP SPARKING AND SMOKING. INSULATION HAS SEPARATED FROM THE COLLAR WHERE IT GOES INTO THE HANDLE ON ALL ITEMS." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23817624 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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